UDI device identifier
Peri-Guard PG0608
UDI device identifier 00085412818443 · SYNOVIS LIFE TECHNOLOGIES, INC.
Key facts
| Primary DI | 00085412818443 |
|---|---|
| Brand name | Peri-Guard |
| Version or model | PG0608 |
| Catalog number | PG0608 |
| Company | SYNOVIS LIFE TECHNOLOGIES, INC. |
| DUNS number | 017415781 |
| Product code | OXB |
| GMDN term | Cardiovascular patch, animal-derived |
| Premarket submission | K221029 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | Yes |
| Publish date | May 15, 2023 |
| Version date | Oct 19, 2023 |
| Description | PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the… |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1–9 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: